🇪🇺 Prasterone (DHEA), Micronized in European Union

EMA authorised Prasterone (DHEA), Micronized on 8 January 2018

Marketing authorisation

EMA — authorised 8 January 2018

  • Application: EMEA/H/C/004138
  • Marketing authorisation holder: Endoceutics S.A.
  • Local brand name: Intrarosa
  • Indication: Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
  • Status: approved

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Prasterone (DHEA), Micronized in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Prasterone (DHEA), Micronized approved in European Union?

Yes. EMA authorised it on 8 January 2018.

Who is the marketing authorisation holder for Prasterone (DHEA), Micronized in European Union?

Endoceutics S.A. holds the EU marketing authorisation.